Will Hidell

Will Hidell from Brookline Capital Markets inquired about the recent decrease in spending and the company's expectations for spending levels over the next year, given the extended cash runway.

Answer

President, CEO & Director David Mazzo explained that future spending levels will depend on the timing of the Phase 3 trial initiation and the results from the BOLSTER trial. He stated that if no new major trials are initiated, the company expects a modest decrease in spending as current clinical trials conclude.

Asked about the expected level of detail in the upcoming ASCEND trial Cohort A data readout and what specific outcomes would be considered positive enough to warrant continued development.

Answer

The data readout is expected to include key endpoints from the public protocol, such as PFS at 6 months, median PFS, median OS, and response rates. For continued development, the company will focus on overall survival (the regulatory standard) and the number of complete responses.

Will Hidell from Brookline Capital Markets asked for an update on the enrollment status of the combination study with Avastin and requested a breakdown of the $3 million raised post-quarter between warrant exercises and the ATM facility.

Answer

President and CEO Dr. Stacy Lindborg confirmed that the Avastin trial is still enrolling, with efforts underway to increase the speed of enrollment, including adding a new high-performing site from the OVATION II study. CFO Kim Graper clarified that the approximately $3 million in net proceeds raised after the quarter's end was split nearly 50/50, with about $1.5 million from warrant exercises and $1.5 million from the ATM facility.

Will Hidell asked if the November grant for Ovaprene covers the cost of adding new trial sites, whether the recent lower R&D expense trend is sustainable, and if the ~$1 million 503B setup cost for Sildenafil applies to other products.

Answer

CEO Sabrina Johnson confirmed the Ovaprene grant covers adding more subjects and that while the current five new sites are enrolling well, there is flexibility to add more. She explained the lower R&D expense reflects that Ovaprene is the only ongoing study and is largely grant-funded, a trend expected to continue until new studies begin. Johnson clarified the ~$1 million cost is specific to Sildenafil's tech transfer, and the hormone therapy product would incur a separate, similar cost in the single-digit millions for its own manufacturing setup.

Will Hidell inquired about any updates on the technology assessment process with NICE in the United Kingdom, noting a deliverable was expected by December.

Answer

Executive C. Trenary responded that the company has submitted a well-informed dossier to NICE and the application has been accepted. He stated they are proceeding through the standard process and will have more clarity on pricing in the U.K. later in the year.